EUROPEAN COMMISSION

Brussels, 22.3.2018

COM(2018) 144 final

2018/0070(COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on persistent organic pollutants (recast)

(Text with EEA relevance)

EXPLANATORY MEMORANDUM

1.CONTEXT OF THE PROPOSAL

•Reasons for and objectives of the proposal

Regulation (EC) No 850/2004 of the European Parliament and of the Council 1 ('the POPs Regulation') implements the commitments of the Union under the Stockholm Convention on Persistent Organic Pollutants (‘the Stockholm Convention’) approved by Council Decision 2006/507/EC 2 and under the Protocol to the 1979 Convention on Long-Range Transboundary Air Pollution on Persistent Organic Pollutants (‘the POPs Protocol’) approved by Council Decision 2004/259/EC 3 .

The following reasons lead to the proposal to recast the POPs Regulation:

•Consistency with existing policy provisions in the policy area

•Consistency with other Union policies

2.LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY

•Legal basis

•Subsidiarity (for non-exclusive competence)

The objectives of the proposal cannot be achieved by the Member States because a harmonised approach is needed to ensure that the Union, as a Party to the Stockholm Convention, meets its international obligations.

•Proportionality

•Choice of the instrument

3.RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS

•Ex-post evaluations/fitness checks of existing legislation

•Stakeholder consultations

•Collection and use of expertise

Due to the limited scope of changes proposed in the context of this review, it was not deemed necessary to make extensive use of external expertise. However, the Agency was consulted on some technical issues.

•Impact assessment

–As a result of the proposed changes, there will be more clarity, transparency and increased legal certainty for all parties involved in the implementation of the Regulation;

–Some tasks will be transferred from the Commission to the Agency, which is expected to reduce the overall costs and to increase the scientific knowledge available for implementation;

–The current high level of protection of human health and the environment will be maintained.

•Regulatory fitness and simplification

•Fundamental rights

4.BUDGETARY IMPLICATIONS

5.OTHER ELEMENTS

•Implementation plans and monitoring, evaluation and reporting arrangements

The proposal contains provisions on monitoring of persistent organic pollutants and on reporting on their manufacturing, use and emissions. In addition, it provides for obligations on monitoring the application of the POPs Regulation. It also requires the setting-up and regular review of a plan for implementation of the Stockholm Convention. As this proposal is a recast of an existing Regulation that already contains those elements, it focuses on taking account of the results of the above-mentioned Fitness Check but does not introduce any additional implementation, monitoring or reporting requirements.

•Detailed explanation of the specific provisions of the proposal

The proposed recast Regulation would essentially maintain all provisions of the current POPs Regulation, including those that go beyond the requirements of the Stockholm Convention and the POPs Protocol. However, certain technical amendments are deemed necessary to improve the clarity and functioning of the Regulation. The main changes are as follows:

–Changes and clarifications as regards certain definitions (Article 2)

In order to ensure that the terminology used in this Regulation is clear and reflects the interpretation of terminology used in chemicals legislation in general, the definitions for ‘placing on the market’, ‘article’, ‘substance’, ‘waste’, ‘disposal’ and ‘recovery’ have been amended. The term ‘preparation’ has been replaced by ‘mixture’ to reflect the changes in the general chemicals legislation. It has also been deemed appropriate to add definitions for 'manufacturing', 'use' and 'closed-system, site-limited intermediate'.

–Involvement of the European Chemicals Agency (Articles 8, 16 and 17)

A role for the Agency in the implementation of this Regulation has been proposed due to the Agency's expertise and experience with the implementation of general chemicals legislation and international agreements on chemicals, in particular regarding its current involvement in REACH and Regulation (EU) No 649/2012.

It is proposed that the role of the Agency will include its involvement in the technical preparation of dossiers on substances that may be used by the Commission, should it use its discretion to propose one or more such substances to be listed as POPs in the Stockholm Convention. In particular, the Agency will take action where substances are considered to fulfil the criteria in Annex D of the Stockholm Convention.

Substances for which there are uses within the scope of the authorisation requirement of REACH, that are considered to fulfil the criteria in Annex D of the Stockholm Convention and which are identified in accordance with Article 59 of REACH due to their persistence and bioaccumulation should, in general, be subject to the restriction procedure under REACH, unless other regulatory measures are deemed to be more appropriate, with a clear indication that the substance may be submitted to the Convention at a later stage. Where such substances have not been identified in accordance with Article 59 of REACH, they should first be subject to that identification procedure or be subject to assessment by the REACH Member State Committee. The Agency must ensure that the restriction dossier is taken into account when preparing the POP dossier, which shall cover information on all known uses of the substance in the Union and not only those considered under REACH. This will ensure a consistent and efficient implementation of legislation on chemicals in the Union and coherence between the work on a potential POP that is carried out under REACH and the international work that is conducted in support of the Stockholm Convention.

The POP dossier should be made subject to the normal stakeholder consultations undertaken by the Agency. This extended process serves the purpose of obtaining stakeholder information at an early stage and provides the evidence base for the Commission to decide whether to propose the substance as a POP under the Stockholm Convention in a draft Decision pursuant to Article 218(9) of the Lisbon Treaty.

–Inclusion of a role for the Forum for Exchange of Information on Enforcement ('the Forum') established by REACH (Article 8(2)).

The Forum is a network of authorities responsible for the enforcement of REACH, Regulation (EC) No 1272/2008 (CLP) and Regulation (EC) 649/2012 (PIC) in the EU. As a result of the experience it has accrued in relation to those chemical regulations, it is deemed appropriate to propose a role for the Forum in coordinating the enforcement tasks specified in this Regulation.

–Adaptation of provisions in the current POPs Regulation related to the comitology procedures to the procedures of the Lisbon Treaty (Articles 4(3), 7(5), 15, 18)

The provisions in which certain powers are conferred upon the European Commission have been revised in order to reflect the entry into force of the Lisbon Treaty.

–Adaptation of the provisions on reporting and monitoring;

Articles 11 and 13 will be updated by more effective provisions which simplify monitoring. It is foreseen that Member States put in place a data set gathering relevant data under this Regulation, in particular Annex III. Collected spatial data sets require compliance with the INSPIRE Directive. To that end, the support of ECHA is foreseen, whose role will also be to regularly compile and assess the data and provide the Commission with Member State and EU overviews of the Regulation's implementation.

ê Corrigendum, OJ L 229, 29.6.2004, p. 5 (adapted)

2018/0070 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on persistent organic pollutants and amending Directive 79/117/EEC (recast)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community Ö Treaty on the Functioning of the European Union Õ , and in particular Article 175(1) Ö 192(1) Õ thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee,

After consulting the Committee of the Regions,

Acting in accordance with the ordinary legislative procedure,

Whereas:

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(1)Regulation (EC) No 850/2004 of the European Parliament and of the Council 14 has been substantially amended several times. Since it is necessary to make further amendments, that Regulation should be recast in the interests of clarity.

ê Corrigendum, OJ L 229, 29.6.2004, p. 5 (adapted)

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(1)    This Regulation primarily concerns environmental protection and the protection of human health. The legal basis is therefore Article 175(1) of the Treaty.

(2)The Community Ö Union Õ is seriously concerned by the continuous release of persistent organic pollutants Ö ("POPs") Õ into the environment. These Those chemical substances are transported across international boundaries far from their sources and they persist in the environment, bioaccumulate through the food web, and pose a risk to human health and the environment. Further measures need therefore to be taken in order to protect human health and the environment against these those pollutants.

(3)In view of its responsibilities for the protection of the environment, the Community Ö Union Õ signed Ö approved Õ on 24 June 1998 Ö 19 February 2004 Õ the Protocol to the 1979 Convention on Long-Range Transboundary Air Pollution on Persistent Organic Pollutants 15 , hereinafter (‘the Protocol’), and Ö approved Õ on 22 May 2001 Ö 14 October 2004 Õ the Stockholm Convention on Persistent Organic Pollutants 16 , hereinafter (‘the Convention’).

(4)    While legislation at Community level relating to persistent organic pollutants has been put in place, its main deficiencies are that there is an absence of, or incomplete legislation on, prohibition of the production and use of any of the currently listed chemicals, that there is no framework to subject additional persistent organic pollutant substances to prohibitions, restrictions or elimination, nor any framework to prevent the production and use of new substances that exhibit persistent organic pollutant characteristics. No emission reduction targets, as such, have been set at Community level and the current release inventories do not cover all sources of persistent organic pollutants.

(4)In order to ensure coherent and effective implementation of the Community's Ö Union's Õ obligations under the Protocol and the Convention, it is necessary to establish a common legal framework, within which to take measures designed in particular to eliminate the production ð manufacturing ï , placing on the market and use of intentionally produced ð manufactured ï persistent organic pollutants Ö POPs Õ . Furthermore, persistent organic pollutants' Ö POPs' Õ characteristics should be taken into consideration in the framework of the relevant Community Ö Union Õ assessment and authorisation schemes.

(5)Coordination and coherence should be ensured wWhen implementing Ö the provisions of the Convention Õ at Community Ö Union Õ level Ö , it is necessary to ensure coordination and coherence with Õ the provisions of the Rotterdam Ö Convention on the prior informed consent procedure for certain hazardous chemicals and pesticides in international trade, which was approved by the Union on 19 December 2002 Õ  17 , Stockholm and Ö of the Õ Basel Conventions Ö on the control of transboundary movements of hazardous wastes and their disposal, which was approved by the Union on 1 February 1993 Õ  18 . and Ö This coordination and coherence should also be maintained Õ when participating in the Ö implementation and further Õ development of the Strategic Approach to International Chemicals Management (SAICM) Ö , adopted by the First International Conference on Chemicals Management in Dubai on 6 February 2006 Õ within the United Nations framework.

(6)Moreover, considering that the provisions of this Regulation are underpinned by the precautionary principle as set forth in the Treaty, and mindful of Ö the precautionary approach to environmental protection as set forth in Õ Principle 15 of the Rio Declaration on Environment and Development and in view of the aim of elimination, where feasible, of the release of persistent organic pollutants Ö POPs Õ into the environment, it is appropriate in certain cases to provide for control measures stricter than those under the Protocol and the Convention.

(8)    In the future, the proposed REACH Regulation could be an appropriate instrument by which to implement the necessary control measures on production, placing on the market and use of the listed substances and the control measures on existing and new chemicals and pesticides exhibiting persistent organic pollutants' characteristics. However, without prejudice to the future REACH Regulation and since it is important to implement these control measures on the listed substances of the Protocol and the Convention as soon as possible, this Regulation should for now implement those measures.

(7)In the Community Ö Union Õ, the placing on the market and use of most of the persistent organic pollutants Ö POPs Õ listed in the Protocol or the Convention has Ö have Õ already been phased out as a result of the prohibitions laid down in ð inter alia, ï Regulation (EC) No 1907/2006 of the European Parliament and of the Council 19 , Regulation (EC) No 1107/2009 of the European Parliament and of the Council 20 and Regulation (EU) No 528/2012 of the European Parliament and of the Council 21  Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances 22 and Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations 23 . However, in order to fulfil the Community's Ö Union's Õ obligations under the Protocol and the Convention and to minimise the release of persistent organic pollutants Ö POPs Õ , it is necessary and appropriate also to prohibit the production ð manufacturing ï of those substances and to restrict exemptions to a minimum so that exemptions only apply where a substance fulfils an essential function in a specific application.

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(8)For reasons of clarity and consistency with other relevant Union legislation, certain definitions should be specified and terminology should be aligned with that used in Regulation (EC) No 1907/2006 and Directive 2008/98/EC of the European Parliament and of the Council 24 .

ê Corrigendum, OJ L 229, 29.6.2004, p. 5 (adapted)

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(9)Exports of substances covered by the Convention and exports of lindane are regulated by Regulation (EC) No 304/2003 of the European Parliament and of the Council of 28 January 2003 concerning the export and import of dangerous chemicals 25  Regulation (EU) No 649/2012 of the European Parliament and of the Council 26  ð and therefore need not be further addressed in this Regulation ï .

(11)    The production and use of hexachlorocyclohexane (HCH), including lindane, is subject to restrictions under the Protocol but not totally prohibited. That substance is still used in some Member States and therefore it is not possible to prohibit immediately all existing uses. However, in view of the harmful properties of HCH and the possible risks related to its release into the environment, its production and uses should be confined to a minimum and ultimately phased out by the end of 2007 at the latest.

(10)Obsolete or carelessly managed stockpiles of persistent organic pollutants Ö POPs Õ may seriously endanger the environment and human health through, for instance, contamination of soil and ground water. It is appropriate, therefore, to Ö lay down stricter rules concerning the management of such stockpiles compared to those Õ adopt provisions that go beyond the provisions laid down in the Convention. Stockpiles of prohibited substances should be treated as waste, while stockpiles of substances the production ð manufacturing ï or use of which is still allowed should be notified to the authorities and properly supervised. In particular, existing stockpiles which consist of or contain banned persistent organic pollutants Ö POPs Õ should be managed as waste as soon as possible. If other substances are banned in the future, their stocks should also be destroyed without delay and no new stockpiles should be built up. In view of the particular problems of certain new Member States, adequate financial and technical assistance should be provided through existing Community financial instruments, such as the Cohesion and Structural Funds.

(11)In line with the Communication from the Commission on the Community Strategy for Dioxins, Furans and Polychlorinated Biphenyls (PCBs) 27 , and with the Protocol and the Convention, releases of persistent organic pollutants Ö POPs Õ which are unintentional by-products of industrial processes should be identified and reduced as soon as possible with the ultimate aim of elimination, where feasible. Appropriate national action plans, covering all sources and measures, including those provided for under existing Community Ö Union Õ legislation, should be drawn up and implemented Ö and developed Õ to reduce the Ö such Õ releases continuously and cost-effectively as soon as possible. To this end, appropriate tools should be developed in the framework of the Convention.

(12)In line with that Communication, aAppropriate programmes and mechanisms should be established Ö or maintained, as appropriate, Õ to provide adequate monitoring data on the presence of dioxins, furans, and Ö polychlorinated biphenyls Õ (PCBs) ð and other relevant POPs ï in the environment. However, it is necessary to ensure that appropriate tools are available and can be used under economically and technically viable conditions.

(13)Under the Convention, the persistent organic pollutant Ö POP Õ content in waste is to be destroyed or irreversibly transformed into substances that do not exhibit similar characteristics, unless other operations are environmentally preferable. Ö In order for the Union to comply with its obligations under the Convention, it is necessary to Õ Since current Community legislation on waste does not lay down specific rules as regards those substances, they should be laid down in this Regulation. To ensure a high level of protection, common concentration limits for the substances in waste should be establishedbefore 31 December 2005 ð , monitored and enforced ï .

(14)The importance of identifying and separating Ö It is important to identify and separate Õ waste consisting of, containing or contaminated by persistent organic pollutants Ö POPs Õ at source in order to minimise the spreading of those chemicals into other waste is recognised. Council Directive 91/689/EEC of 12 December 1991 on hazardous waste 28  Directive 2008/98/EC established Ö establishes Õ Community Ö Union Õ rules on the management of hazardous waste obliging Member States to take the necessary measures to require that establishments and undertakings which dispose of, recover, collect or transport hazardous waste do not mix different categories of hazardous waste or mix hazardous waste with non-hazardous waste.

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(15)There is a need to ensure the effective coordination and management of technical and administrative aspects of this Regulation at Union level. The European Chemicals Agency ("the Agency"), established by Regulation (EC) No 1907/2006, has the competence and experience in implementing Union legislation on chemicals and international agreements on chemicals. The Member States and the Agency should, therefore, carry out tasks with regard to the administrative, technical and scientific aspects of the implementation of this Regulation and the exchange of information. The role of the Agency should include the preparation and examination of technical dossiers, including stakeholder consultations, and the drawing up of opinions that may be used by the Commission in considering whether to come forward with a proposal for listing a substance as a POP in the Convention or the Protocol. In addition, the Commission, the Member States and the Agency should cooperate in order to implement the Union's international obligations under the Convention effectively.

ê Corrigendum, OJ L 229, 29.6.2004, p. 5 (adapted)

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(16)The Convention provides that each Party is to draw up ð and endeavour to implement, as appropriate, ï a plan for the implementation of its obligations under the Convention. Member States should provide opportunities for public participation in drawing up ð , implementing and updating ï their implementation plans. Since the Community Ö Union Õ and the Member States share competence in that regard, implementation plans should be drawn up both at national and Community Ö Union Õ level. Cooperation and an exchange of information between the Commission ð , the Agency ï and the authorities of the Member States should be promoted.

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(17)Substances listed in Part A to Annex I or Part A to Annex II to this Regulation should only be allowed to be manufactured and used as closed-system site-limited intermediates if an annotation to that effect is expressly entered in that Annex and if the manufacturer confirms to the Member State concerned that the substance is only manufactured and used under strictly controlled conditions.

ê Corrigendum, OJ L 229, 29.6.2004, p. 5 (adapted)

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(18)In accordance with the Convention and the Protocol, information on persistent organic pollutants Ö POPs Õ should be provided to other Parties Ö to those Agreements Õ . The exchange of information with third countries not party to those Agreements should also be promoted.

(19)Ö Since Õ pPublic awareness of the hazards that persistent organic pollutants Ö POPs Õ pose to the health of present and future generations as well as to the environment, particularly in developing countries, is often lacking, and wide-scale information is therefore needed to increase the level of caution and gain support ð public understanding of the rationale ï for restrictions and bans. In accordance with the Convention, public awareness programmes on these those substances, especially for the most vulnerable groups, as well as training of workers, scientists, educators, technical and managerial personnel should be promoted and facilitated, as appropriate.

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(20)In order to promote the development of a comprehensive chemical exposure and toxicity knowledge base, in line with the General Union Environment Action Programme to 2020 "Living well, within the limits of our planet" (the 7th EAP) 29 , the Commission has established the Information Platform for Chemical Monitoring 30 . The use of this platform should be encouraged as a means for Member States to comply with their obligations to report chemical occurrence data and to simplify and reduce their reporting obligations.

ê Corrigendum, OJ L 229, 29.6.2004, p. 5 (adapted)

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(21)Upon request and within available resources, the Commission ð , the Agency ï and the Member States should cooperate in providing appropriate and timely technical assistance designed especially to strengthen the capacity of developing countries and countries with economies in transition to implement the Convention. Technical assistance should include the development and implementation of suitable alternative products, methods and strategies, inter alia, to the use of DDT in disease vector control which, under the Convention, can only be used in accordance with World Health Organisation recommendations and guidelines and ð to ensure that POPs only continue to be used ï when locally safe, effective and affordable alternatives are not available to the country in question.

(22)There should be regular evaluation of the effectiveness of the measures taken to reduce releases of persistent organic pollutants Ö POPs Õ . To that end, Member States should report regularly ð , in standardised form, ï to the Commission ð Agency ï , in particular as regards release inventories, notified stockpiles and the production ð manufacturing ï and placing on the market of restricted substances. The Commission, in cooperation with Member States, should develop a common format for Member States' reports.

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(23)To address the need for information on implementation and compliance, an alternative system of collecting and making information available should be introduced taking account of the results of the Commission Report on Actions to Streamline Environmental Reporting 31 and its related Fitness Check. In particular, Member States should make accessible all relevant data. This should ensure that the administrative burden on all entities remains as limited as possible. It requires that active dissemination at national level should be done in accordance with Directive 2003/4/EC of the European Parliament and of the Council 32 and Directive 2007/2/EC of the European Parliament and of the Council (INSPIRE) 33 , to ensure the appropriate infrastructure for public access, reporting and data-sharing between public authorities. In that context, Member States and the Agency should base the specifications for spatial data on the implementing acts adopted under Directive 2007/2/EC.

ê Corrigendum, OJ L 229, 29.6.2004, p. 5 (adapted)

(24)The Convention and the Protocol provide that Parties thereto may propose other Ö additional Õ substances for international action and consequently additional substances may be listed under those Agreements,. iIn which case Ö such cases, Õ this Regulation should be amended accordingly. Furthermore, it should be possible to modify the existing entries in Annexes to this Regulation, inter alia for the purposes of adapting them to scientific and technical progress.

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(25)The power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to permit, where appropriate, the manufacture and use of a substance listed in Part A to Annex I or Part A to Annex II to this Regulation as a closed-system site-limited intermediate, to establish concentration limits for a substance for the purposes of Annexes IV and V and to amend the Annexes to this Regulation in order to adapt them to any change to the list of substances set out in the Annexes to the Convention or the Protocol as well as to modify existing entries or provisions in the Annexes to this Regulation in order to adapt them to scientific and technical progress.

(26)It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council should receive all documents at the same time as Member States' experts, and their experts should systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

ê Corrigendum, OJ L 229, 29.6.2004, p. 5 (adapted)

(27)When Annexes to this Regulation are amended to implement any listings of an additional, intentionally produced persistent organic pollutant Ö POP Õ in the Protocol or in the Convention, it Ö the listing Õ should be included in Annex II, instead of Annex I, only in exceptional cases and when duly justified.

(24)    The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission 34

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(28)In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission to adopt additional measures relating to waste management and to specify the minimum information to be provided by Member States in monitoring the implementation of this Regulation. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council 35 .

ê Corrigendum, OJ L 229, 29.6.2004, p. 5 (adapted)

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(29)In order to ensure transparency, impartiality and consistency at the level of enforcement activities, Member States should lay down rules on penalties applicable to infringements of the provisions of this Regulation and ensure that they are implemented. Those penalties should be effective, proportionate and dissuasive, since non-compliance can result in damage to human health and the environment. ð To ensure consistent and effective enforcement of this Regulation, the Member States should coordinate relevant activities and exchange information in the Forum for Exchange of Information on Enforcement established under Regulation (EC) No 1907/2006. ï Information on infringements of the provisions of this Regulation should be made public, where appropriate.

(30)Since the objectives of this Regulation, namely to protect the environment and human health from persistent organic pollutants Ö POPs Õ , cannot be sufficiently achieved by the Member States, owing to the transboundary effects of those pollutants, and can therefore be better achieved at Community Ö Union Õ level, the Community Ö Union Õ may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty Ö on the European Union Õ . In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives,

In the light of the above, Directive 79/117/EEC should be amended,

HAVE ADOPTED THIS REGULATION

Article 1

Objective and scope Ö Subject matter Õ

1. Taking into account, in particular, the precautionary principle, the objective of tThis Regulation is Ö lays down rules, underpinned by the precautionary principle, Õ to protect human health and the environment from persistent organic pollutants Ö POPs Õ by prohibiting, phasing out as soon as possible, or restricting the production ð manufacturing ï , placing on the market and use of substances subject to the Stockholm Convention on Persistent Organic Pollutants, hereinafter ‘the Convention’, or the 1998 Protocol to the 1979 Convention on Long-Range Transboundary Air Pollution on Persistent Organic Pollutants, hereinafter ‘the Protocol’, and by minimising, with a view to eliminating where feasible as soon as possible, releases of such substances, and by establishing provisions regarding waste consisting of, containing or contaminated by any of these those substances.

2. Articles 3 and 4 shall not apply to waste consisting of, containing or contaminated by any substance listed in Annexes I or II.

Article 2

Definitions

For the purposes of this Regulation:

(a)‘placing on the market’ means supplying or making available to third persons against Ö , whether in return for Õ payment or free of charge Ö , to a third party Õ . Imports into the customs territory of the Community Ö Union Õ shall also be deemed to be placed Ö placing Õ on the market;

(b)‘article’ means an object composed of one or more substances and/or preparations Ö mixtures Õ which during production is given a specific Ö special Õ shape, surface or design determining Ö which determines Õ its end use function to a greater extent Ö degree Õ than Ö does Õ its chemical composition does;

(c)‘substance’ is as defined in Article 2 of Council Directive 67/548/EEC 36  Ö means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition Õ ;

(d) ‘preparation’ is as defined in Article 2 of Directive 67/548/EEC Ö ‘mixture’ means a mixture or solution composed of two or more substances Õ;

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(e)‘manufacturing’ means production or extraction of substances in the natural state;

(f)‘use’ means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation;

ê Corrigendum, OJ L 229, 29.6.2004, p. 5 (adapted)

(ge) ‘waste’ Ö means any substance or object which the holder discards or intends or is required to discard Õ is as defined in Article 1(a) of Council Directive 75/442/EEC 37 ;

(hf) ‘disposal’ Ö means any operation which is not recovery even where the operation has as a secondary consequence the reclamation of substances or energy Õ is as defined in Article 1(e) of Directive 75/442/EEC;

(ig) ‘recovery’ Ö means any operation the principal result of which is waste serving a useful purpose by replacing other materials which would otherwise have been used to fulfil a particular function, or waste being prepared to fulfil that function, in the plant or in the wider economy Õ is as defined in Article 1(f) of Directive 75/442/EEC.;

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(j)'closed system site-limited intermediate' means a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into one or more other substances and where the manufacture of the intermediate and its transformation into one or more other substances take place on the same site under strictly controlled conditions in that it is rigorously contained by technical means during its whole lifecycle.

ê Corrigendum, OJ L 229, 29.6.2004, p. 5 (adapted)

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Article 3

Control of production Ö manufacturing Õ , placing on the market and use

1. The ð manufacturing ï production, placing on the market and use of substances listed in Annex I, whether on their own, in preparation Ö mixtures Õ or as constituents of articles, shall be prohibited.

2. The production ð manufacturing ï , placing on the market and use of substances listed in Annex II, whether on their own, in preparation Ö mixtures Õ or as constituents of articles, shall be restricted in accordance with the conditions set out in that Annex.

3. Member States and the Commission shall, within the assessment and authorisation schemes for existing and new chemicals and pesticides Ö substances Õ under the relevant Community Ö Union Õ legislation, take into consideration the criteria set out in paragraph 1 of Annex D to the Convention and take appropriate measures to control existing chemicals and pesticides and prevent the production ð manufacturing ï , placing on the market and use of new chemicals and pesticides, which exhibit characteristics of persistent organic pollutants Ö POPs Õ .

Article 4

Exemptions from control measures

1. Article 3 shall not apply in the case of:

(a) a substance used for laboratory-scale research or as a reference standard;

(b) a substance occurring as an unintentional trace contaminant in substances, preparations Ö mixtures Õ or articles.;

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(c) waste consisting of, containing or contaminated by any substance listed in Annex I or II.

ê Corrigendum, OJ L 229, 29.6.2004, p. 5 (adapted)

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2. ð For a substance added to Annex I or II after [date of entry into force of this Regulation], ï Article 3 shall not apply ð for a six months period ï in respect of substances occuring Ö if that substance occurs Õ as a constituent of articles produced before or on the date ð that this Regulation becomes applicable to that substance ï of entry into force of this Regulation until six months after the date of its entry into force.

Article 3 shall not apply in the case of a substance occurring as a constituent of articles already in use before or on the date of entry into force of this Regulation ð that this Regulation or Regulation (EC) No 850/2004 became applicable to that substance, whichever date came first ï .

However, immediately upon becoming aware of articles referred to in the first and second subparagraph, a Member State shall inform the Commission ð and the European Chemicals Agency established by Regulation (EC) No 1907/2006 ("the Agency") ï accordingly.

Whenever the Commission is so informed or otherwise learns of such articles, it shall, where appropriate, notify the Secretariat of the Convention accordingly without further delay.

3. Where a substance is listed in Part A of Annex I or in Part A of Annex II, a Member State wishing to permit, until the deadline specified in the relevant Annex, the production ð manufacturing ï and use of that substance as a closed-system site-limited intermediate shall notify accordingly the Secretariat of the Convention.

However, such notification may be made only if the following conditions are satisfied:

(a)an annotation has been entered in the relevant Annex ð , by means of a delegated act in accordance with Article 18, ï expressly to the effect that such production ð manufacturing ï and use of that substance may be permitted;

(b)ð the manufacturer demonstrates that ï the manufacturing process will transform the substance into one or more other substances that do not exhibit the characteristics of a persistent organic pollutant Ö POP Õ ;

(c) it is not expected that either humans or the environment will be exposed to any significant quantities of the substance during its production and use, as shown through assessment of that closed system in accordance with Commission Directive 2001/59/EC 38 .

ò new

(c)the manufacturer confirms that the substance is a closed-system site-limited intermediate within the meaning of Article 2(j).

ê Corrigendum, OJ L 229, 29.6.2004, p. 5 (adapted)

ð new

The notification shall be communicated also to the other Member States, and to the Commission ð and the Agency ï and shall give details of actual or estimated total production ð manufacturing ï and use of the substance concerned and the nature of the closed-system site-limited process, specifying the amount of any non-transformed and unintentional trace contamination by any persistent organic pollutant Ö POP Õ starting material in the final product.

ð The Commission is empowered to adopt delegated acts in accordance with Article 18 ï Ö in order to amend Õ Tthe deadlines Ö in an annotation Õ referred to in the first second subparagraph may be amended in cases where, following a repeat notification from the Member State concerned to the Secretariat of the Convention, express or tacit consent is issued under the Convention for the continued production ð manufacturing ï and use of the substance for another period.

ò new

4. Paragraphs 2 and 3 shall not apply to waste consisting of, containing or contaminated by any substance listed in Annexes I or II.

ê Corrigendum, OJ L 229, 29.6.2004, p. 5 (adapted)

ð new

Article 5

Stockpiles

1. The holder of a stockpile, which consists of or contains any substance listed in Annex I or Annex II, for which no use is permitted, shall manage that stockpile as waste and in accordance with Article 7.

2. The holder of a stockpile greater than 50 kg, consisting of or containing any substance listed in Annex I or Annex II, and the use of which is permitted shall provide the competent authority of the Member State in which the stockpile is established with information concerning the nature and size of that stockpile. Such information shall be provided within 12 months of the ð date that this Regulation or ï entry into force of this Regulation Ö (EC) No 850/2004 Õ ð became applicable to that substance, whichever date came first for the holder, ï and of Ö relevant Õ amendments to Annexes I or II and annually thereafter until the deadline specified in Annex I or II for restricted use.

The holder shall manage the stockpile in a safe, efficient and environmentally sound manner.

3. Member States shall monitor the use and management of notified stockpiles.

Article 6

Release reduction, minimisation and elimination

1. Within two years of the date of entry into force of ð this Regulation or ï this Regulation Ö (EC) No 850/2004, Õ ð whichever date came first ï , Member States shall draw up and maintain release inventories for the substances listed in Annex III Ö released Õ into air, water and land in accordance with their obligations under the Convention and the Protocol Ö and shall subsequently maintain such inventories Õ .

2. A Member State Ö States Õ shall communicate its Ö their Õ action plan Ö plans Õ on measures to identify, characterise and minimise, with a view to eliminating where feasible as soon as possible, the total releases Ö of substances listed in Annex III Õ developed Ö as recorded in their inventories drawn up Õ in accordance with its Ö their Õ obligations under the Convention, to both the Commission ð , the Agency ï and Ö to Õ the other Member States as part of its Ö their Õ national implementation plan Ö plans Õ , pursuant to Article 9 8.

The Ö Such Õ action plan Ö plans Õ shall include measures to promote the development Ö of, Õ and, where Ö it is considered Õ deems appropriate, shall require the use of substitute or modified materials, products ð substances, mixtures, articles ï and processes to prevent the formation and release of the substances listed in Annex III.

3. Member States shall, when considering proposals to construct new facilities or Ö to Õ significantlyto modify existing facilities using processes that release chemicals listed in Annex III, without prejudice to Council Directive 1996/61/EC 39 , give priority consideration to alternative processes, techniques or practices that have similar usefulness but which avoid the formation and release of substances listed in Annex III Ö , without prejudice to Directive 2010/75/EU of the European Parliament and of the Council 40  Õ .

Article 7

Waste management

1. Producers and holders of waste shall undertake all reasonable efforts to avoid, where feasible, contamination of this waste with substances listed in Annex IV.

2. Notwithstanding Council Directive 96/59/EC 41 , waste consisting of, containing or contaminated by any substance listed in Annex IV shall be disposed of or recovered, without undue delay and in accordance with part 1 of Annex V, part 1 in such a way as to ensure that the persistent organic pollutant Ö POP Õ content is destroyed or irreversibly transformed so that the remaining waste and releases do not exhibit the characteristics of persistent organic pollutants Ö POPs Õ .

In carrying out such a disposal or recovery, any substance listed in Annex IV may be isolated from the waste, provided that this substance is subsequently disposed of in accordance with the first subparagraph.

3. Disposal or recovery operations that may lead to recovery, recycling, reclamation or re-use of the substances listed in Annex IV shall be prohibited.

4. By way of derogation from paragraph 2:

ê 219/2009 Art. 1 and Annex .3(7) (adapted)

(a) waste containing or contaminated by any substance listed in Annex IV may be otherwise disposed of or recovered in accordance with the relevant Community Ö Union Õ legislation, provided that the content of the listed substances in the waste is below the concentration limits to be specified in Annex IV. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 17(3). Until such time as concentration limits are established in accordance with such procedure, the competent authority of a Member State may adopt or apply concentration limits or specific technical requirements in respect of the disposal or recovery of waste under this point.

ê Corrigendum, OJ L 229, 29.6.2004, p. 5 (adapted)

è1 219/2009 Art. 1 and Annex .3(7)

ð new

(b) a Member State or the competent authority designated by that Member State may, in exceptional cases, allow wastes listed in part 2 of Annex V, part 2 containing or contaminated by any Ö a Õ substance listed in Annex IV up to concentration limits to be specified in part 2 of Annex V, part 2, to be otherwise dealt with in accordance with a method listed in part 2 of Annex V, part 2 provided that Ö the following conditions are fullfilled Õ :

(i) the holder concerned has demonstrated to the satisfaction of the competent authority of the Member State concerned that decontamination of the waste in relation to substances listed in Annex IV was not feasible, and that destruction or irreversible transformation of the persistent organic pollutant Ö POP Õ content, performed in accordance with best environmental practice or best available techniques, does not represent the environmentally preferable option and the competent authority has subsequently authorised the alternative operation;

(ii) this Ö the Õ operation is in accordance with relevant Community Ö Union Õ legislation and Ö with Õ the conditions laid down in relevant additional measures referred to in paragraph 6;

(iii) the Member State concerned has informed the other Member States ð , the Agency ï and the Commission of its authorisation and the justification for it.

5.è1  ð The Commission is empowered to adopt delegated acts in accordance with Article 18 to amend Annex IV and part 2 of Annex V ï Ö in order to establish Õ Cconcentration limits in Annex V, part 2 shall be established by the Commission for the purposes of paragraph 4(b) of this Article. Those measures, designed non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 17(3).

 çUntil such time as these those concentration limits are established:,

(a) the competent authority Ö of a Member State Õ may adopt or apply concentration limits or specific technical requirements in respect Ö for the purposes Õ of waste being dealt with under paragraph 4(b);.

   (b) where Ö In respect of Õ waste is being dealt with under paragraph 4(b), the holders concerned shall provide information on the persistent organic pollutant Ö POP Õ content of the waste to the competent authority.

6. The Commission may, where appropriate, and taking into consideration technical developments and relevant international guidelines and decisions and any authorisations granted by a Member State, or Ö by Õ the competent authority designated by that Member State in accordance with paragraph 4 and Annex V, adopt ð , by means of implementing acts, ï additional measures relating to the implementation of this Article. Ö In particular, Õ Tthe Commission shall ð may ï define a format for the submission of Ö specify Õ the information Ö to be submitted Õ by Member States in accordance with paragraph 4(b)(iii). Such measures shall be decided in accordance with the ð advisory ï procedure laid down in Article 1720(2).

7. The Commission shall, before 31 December 2009, review the derogations in paragraph 4 in the light of international and technical developments, in particular with regard to their environmental preferability.

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Article 8

Tasks of the Agency

1. The Agency shall, in addition to the tasks allocated to it under Articles 9, 10, 11, 13 and 17, carry out the following tasks:

(a)provide the designated competent authorities of the Member States, with the agreement of the Commission, with assistance and technical and scientific guidance in order to ensure the effective application of this Regulation;

(b)upon request, provide the Commission with technical and scientific input and assist it in order to ensure the effective implementation of this Regulation;

(c)upon request, provide technical and scientific support and input to the Commission for substances that may comply with the criteria for listing in the Convention or the Protocol;

(d)upon request, provide the Commission with technical and scientific support in the preparation and review of the risk profile and the risk management evaluation of a substance considered under the Stockholm Convention;

(e)upon request, provide the Commission with technical and scientific support in implementing the Convention, in particular with respect to the POPs Review Committee;

(f)compile, register, process and make available to the Commission and the competent authorities of the Member States all the information received or available pursuant to Article 4(2) and (3), Article 7(4)(b)(iii), Article 9(2), Article 13(1). The Agency shall make the non-confidential information publicly available on its website and shall facilitate the exchange of that information with relevant information platforms such as those referred to in Article 13(2);

(g)establish and maintain sections on its website for all matters relating to the implementation of this Regulation.

2. The Forum for Exchange of Information on Enforcement established by Regulation (EC) No 1907/2006 shall be used to coordinate activities of the Member States' authorities responsible for enforcement of this Regulation.

3. The Secretariat of the Agency shall carry out the tasks allocated to the Agency under this Regulation.

ê Corrigendum, OJ L 229, 29.6.2004, p. 5 (adapted)

ð new

Article 8 9

Implementation plans

1. When preparing ð and updating ï their national implementation plans, Member States shall, in accordance with their national procedures, give the public early and effective opportunities to participate in this process.

2. As soon as a Member State has adopted its national implementation plan in accordance with its obligations under the Convention, it shall ð make it publicly available and ï communicate it Ö its publication Õ both to the Commission ð , the Agency ï and to the other Member States.

3. When Ö Member States are Õ preparing ð and updating ï their implementation plans, the Commission ð , supported by the Agency, ï and the Member States shall exchange information on the content, as appropriate.

4. The Commission ð , supported by the Agency, ï shall, within two years of the entry into force of this Regulation, draw up Ö maintain Õ a plan for the implementation of Community Ö Union Õ obligations under the Convention.

As soon as the Commission has adopted the Community implementation plan, it shall communicate it to the Member States.

The Commission Ö and Õ shall ð publish, ï review and update the Community implementation that Ö plan Õ , as appropriate.

Article 9 10

Monitoring

The Commission ð , supported by the Agency, ï and the Member States shall establish Ö or maintain, as appropriate Õ , in close cooperation, appropriate programmes and mechanisms, consistent with the state of the art, for the regular provision of comparable monitoring data on the presence of dioxins, furans and PCBs as identified in Annex III in the environment. When establishing Ö or maintaining Õ such programmes and mechanisms, due account shall be taken of developments under the Protocol and the Convention.

Article 10 11

Information exchange

1. The Commission ð , the Agency ï and the Member States shall facilitate and undertake the exchange within the Community Ö Union Õ and with third countries of information relevant to the reduction, minimisation or elimination, where feasible, of the production ð manufacturing ï , use and release of persistent organic pollutants Ö POPs Õ and to alternatives to those substances, specifying the risks and the economic and social costs related to such alternatives.

2. The Commission ð , the Agency ï and Ö the Õ Member States, as appropriate, shall promote and facilitate with regard to persistent organic pollutants Ö POPs Õ :

(a) awareness programmes, including relating to their health and environmental effects and their alternatives and on the reduction or elimination of their production ð manufacture ï , use and release, especially for:

(i) policy and decision makers,

(ii) particularly vulnerable groups;

(b) the provision of public information;

(c) training, including workers, scientists, educators and technical and managerial personnel.

3. Without prejudice to Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information 42 , information ð referred to in paragraphs 1 and 2 ï on health and safety of humans and the environment shall not be regarded as confidential. The Commission ð , the Agency ï and the Member States that exchange other information with a third country shall protect any confidential information ð in accordance with Union law ï as mutually agreed.

Article 11 12

Technical assistance

In accordance with Articles 12 and 13 of the Convention, the Commission and the Member States shall cooperate in providing appropriate and timely technical and financial assistance to developing countries and countries with economies in transition to assist them, upon request and within available resources and taking into account their particular needs, to develop and strengthen their capacity to fully implement their obligations under the Convention. Such support may also be channelled through non-governmental organisations ð or the Agency ï .

Article 12 13

Reporting Ö Monitoring of implementation Õ

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1. Without prejudice to Directive 2003/4/EC and Directive 2007/2/EC, Member States shall draw up, publish and keep up-to-date a report containing:

ê Corrigendum, OJ L 229, 29.6.2004, p. 5 (adapted)

ð new

(a)1. Member States shall every three years forward to the Commission information on the application of this Regulation, including information on ð enforcement activities, ï infringements and penalties.;

3. Within three years of the date of entry into force of this Regulation and every three years thereafter Member States shall provide the Commission with:

(ab)summary information compiled from the notifications, concerning stockpiles, received pursuant to ð Article 4(2) and (3), ï Article 5(2) ð and Article 7(4)(b)(iii) ï ;

(bc)summary information compiled from the release inventories drawn up pursuant to Article 6(1);

ò new

(d)information on implementation in accordance with the national implementation plans drawn up pursuant to Article 9(2);

ê Corrigendum, OJ L 229, 29.6.2004, p. 5 (adapted)

ð new

(ce)summary information on the presence of dioxins, furans and PCBs as identified in Annex III in the environment, as compiled pursuant to Article 9. 10; 

(f)2. Member States shall provide the Commission every year with Ö annual Õ ð monitoring and ï statistical data on the actual or estimated total production ð manufacturing ï and placing on the market of any substance listed in Annex I or II ð , including relevant indicators, overview maps, reports ï .

ò new

Members States shall give the Commission and the Agency access to the information contained in the reports.

2. Where a Member State shares the information referred to in paragraph 1(e) with the Information Platform for Chemical Monitoring, this shall be indicated by that Member State in its report and the Member State shall be considered to have fulfilled its reporting obligations under that point.

Where the information referred to in paragraph 1(e) is contained in the report of a Member State provided to the Agency, the Agency shall use the Information Platform for Chemical Monitoring for compiling, storing and sharing that information.

ê Corrigendum, OJ L 229, 29.6.2004, p. 5 (adapted)

ð new

4. As regards the data and information to be provided by Member States pursuant to paragraphs 1, 2 and 3, the Commission shall develop in advance a common format in accordance with the procedure referred to in Article 16(2).

53. Regarding the substances listed in the Convention, the Commission ð , supported by the Agency, ï shall, at Ö the Õ intervals to be determined by the Conference of the Parties of the Convention, compile a report on the basis of the information provided by the Member States ð to the Agency ï in accordance with paragraph 2 1(f) and communicate it to the Secretariat of the Convention.

6. The Commission shall every three years compile a report on the application of this Regulation and shall integrate it with the information already available in the context of the EPER, as established by Commission Decision 2000/479/EC 43 , and CORINAIR Emission Inventory of EMEP (Cooperative Programme for Monitoring and Evaluation of the Long-Range Transmission of Air Pollutants in Europe), and with the information provided by the Member States under paragraphs 1, 2 and 3 to form a synthesis report. This report shall include information on the use of derogations as referred to in Article 7(4). It shall forward a summary of the synthesis report to the European Parliament and to the Council and make it available to the public without delay.

ò new

4. The Agency shall compile and publish a Union overview on the basis of the data referred to in paragraphs 1 and 2 that is published or notified by the Member States. The Union overview shall include, as appropriate, indicators for outputs, results and impacts of this Regulation, Union overview maps and Member State reports. The Union overview shall be updated by the Agency at least once every six months or following receipt of a request from the Commission.

5. The Commission may adopt implementing acts further specifying the minimum information to be provided in accordance with paragraph 1, including the definition of indicators, maps and Member State overviews referred to in paragraph 1(f). Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 20(2).

ê Corrigendum, OJ L 229, 29.6.2004, p. 5 (adapted)

Article 13 14

Penalties

Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Ö Where Õ Member States Ö have not already done so before the entry into force of this Regulation, they Õ shall notify those provisions to the Commission one year after entry into force of this Regulation at the latest and shall notify it without delay of any subsequent amendment affecting them.

Article 14 15

Amendment of Annexes

1. Whenever a substance is listed in the Convention or the Protocol, the Commission shall, where appropriate, amend Annexes I, II and III accordingly.

Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 16(3).

2. Whenever a substance is listed in the Convention or the Protocol, the Commission shall, where appropriate, amend Annex IV accordingly.

Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 17(3).

3. The Commission shall adopt modifications to the existing entries in Annexes I, II and III, including their adaptation to scientific and technical progress.

Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 16(3).

4. The Commission shall adopt modifications to the existing entries in Annex IV and modifications to Annex V, including their adaptation to scientific and technical progress.

Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 17(3).

ò new

The Commission is empowered to adopt delegated acts, in accordance with Article 18, to amend the Annexes to this Regulation in order to adapt them to changes to the list of substances set out in the Annexes to the Convention or the Protocol or to modify existing entries or provisions in the Annexes to this Regulation in order to adapt them to scientific and technical progress.

Article 16

The budget of the Agency

1. For the purposes of this Regulation, the revenues of the Agency shall consist of:

(a)    a subsidy from the Union, entered in the general budget of the Union (Commission Section);

(b)    any voluntary contribution from the Member States.

2. Revenues and expenditure for activities under this Regulation shall be combined with those relating to activities under Regulation (EU) No 649/2012 and shall be reflected in the same section in the Agency’s budget. The revenues of the Agency referred to in paragraph 1 shall be used for carrying out its tasks under this Regulation.

Article 17

Formats and software for publication or notification of information

The Agency shall specify formats and software for the publication or notification of data by Member States pursuant to this Regulation and make them available free of charge on its website. In relation to spatial data sets, Member States and the Agency shall design the formats in accordance with the requirements of Directive 2007/2/EC. Member States and other parties subject to this Regulation shall use those formats and software in their data management or data exchange with the Agency.

Article 18

Exercise of the delegation

1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2. The power to adopt delegated acts referred to in Articles 4(3), 7(5) and 15 shall be conferred on the Commission for an indeterminate period of time from […].

3. The delegation of power referred to in Articles 4(3), 7(5) and 15 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016.

5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6. A delegated act adopted pursuant to Articles 4(3), 7(5) and 15 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of [two months] of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by one month at the initiative of the European Parliament or of the Council.

ê Corrigendum, OJ L 229, 29.6.2004, p. 5 (adapted)

ð new

Article 15 19

Competent authorities

Each Member State shall designate the Ö a Õ competent authority or authorities responsible for the administrative tasks ð and enforcement ï required by this Regulation. It shall inform the Commission of such designation at the latest three months after the entry into force of this Regulation ð , unless it has already done so before the entry into force of this Regulation, and shall also inform the Commission of any change of a designated competent authority ï .

Article 1620

Committee Ö procedure Õ for general matters

1. The Commission shall be assisted by the Committee established by Article 29 of Directive 67/548/EEC 133 of Regulation (EC) No 1907/2006 for all matters under this Regulation except for those relating to waste.

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC ð Article 4 of Regulation (EU) No 182/2011 ï shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

Article 17

Committee for waste matters

1. The Commission shall be assisted by the Committee established by Article 18 of Directive 75/442/EEC, for matters relating to waste under this Regulation.

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

Article 18

Amendments to Directive 79/117/EEC

In Part B of the Annex to Directive 79/117/EEC, ‘Persistent organochlorine compounds’, items 1 to 8 shall be deleted.

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Article 21

Repeal

Regulation (EC) No 850/2004 is repealed.

References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex VII.

ê Corrigendum, OJ L 229, 29.6.2004, p. 5

Article 19 22

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels,

Legislative financial statement ‘Agencies’

1.    FRAMEWORK OF THE PROPOSAL/INITIATIVE

   1.1.    Title of the proposal/initiative

   1.2.    Policy area(s) concerned in the ABM/ABB structure

   1.3.    Nature of the proposal/initiative

   1.4.    Objective(s)

   1.5.    Grounds for the proposal/initiative

   1.6.    Duration and financial impact

   1.7.    Management mode(s) planned

2.    MANAGEMENT MEASURES

   2.1.    Monitoring and reporting rules

   2.2.    Management and control system

   2.3.    Measures to prevent fraud and irregularities

3.    ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE

   3.1.    Heading(s) of the multiannual financial framework and expenditure budget line(s) affected

   3.2.    Estimated impact on expenditure 

   3.2.1.    Summary of estimated impact on expenditure

   3.2.2.    Estimated impact on [body]'s appropriations

   3.2.3.    Estimated impact on [body]'s human resources

   3.2.4.    Compatibility with the current multiannual financial framework

   3.2.5.    Third-party contributions

   3.3.    Estimated impact on revenue

LEGISLATIVE FINANCIAL STATEMENT

1.FRAMEWORK OF THE PROPOSAL/INITIATIVE

1.1.Title of the proposal/initiative

Proposal for a Regulation of the European Parliament and of the Council on persistent organic pollutants (recast)

1.2.Policy area(s) concerned in the ABM/ABB structure 44  

Policy area: 07 Environment

Activity: 07 02 : Environmental policy at Union and international level

1.3.Nature of the proposal/initiative

◻ The proposal/initiative relates to a new action

◻ The proposal/initiative relates to a new action following a pilot project/preparatory action 45  

X The proposal/initiative relates to the extension of an existing action 

◻ The proposal/initiative relates to an action redirected towards a new action 

1.4.Objective(s)

1.4.1.The Commission's multiannual strategic objective(s) targeted by the proposal/initiative

1.4.2.Specific objective(s) and ABM/ABB activity(ies) concerned

1.4.3.Expected result(s) and impact

Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted.

1.4.4.Indicators of results and impact

Specify the indicators for monitoring implementation of the proposal/initiative.

1.5.Grounds for the proposal/initiative

1.5.1.Requirement(s) to be met in the short or long term

1.5.2.Added value of EU involvement

1.5.3.Lessons learned from similar experiences in the past

1.5.4.Compatibility and possible synergy with other appropriate instruments

1.6.Duration and financial impact

◻ Proposal/initiative of limited duration

◻    Proposal/initiative in effect from [DD/MM]YYYY to [DD/MM]YYYY

◻    Financial impact from YYYY to YYYY

X Proposal/initiative of unlimited duration

Implementation with a start-up period from 2018 to 2019,

followed by full-scale operation.

1.7.Management mode(s) planned 46  

X Direct management by the Commission through

◻    executive agencies

◻ Shared management with the Member States

X Indirect management by entrusting budget implementation tasks to:

◻ international organisations and their agencies (to be specified);

◻the EIB and the European Investment Fund;

X bodies referred to in Articles 208 and 209;

◻ public law bodies;

◻ bodies governed by private law with a public service mission to the extent that they provide adequate financial guarantees;

◻ bodies governed by the private law of a Member State that are entrusted with the implementation of a public-private partnership and that provide adequate financial guarantees;

◻ persons entrusted with the implementation of specific actions in the CFSP pursuant to Title V of the TEU, and identified in the relevant basic act.

Comments

2.MANAGEMENT MEASURES

2.1.Monitoring and reporting rules

Specify frequency and conditions.

2.2.Management and control system

Risk(s) identified

Control method(s) envisaged

2.3.Measures to prevent fraud and irregularities

Specify existing or envisaged prevention and protection measures.

3.ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE

3.1.Heading(s) of the multiannual financial framework and expenditure budget line(s) affected

Existing budget lines

In order of multiannual financial framework headings and budget lines.

New budget lines requested

In order of multiannual financial framework headings and budget lines.

3.2.Estimated impact on expenditure

3.2.1.Summary of estimated impact on expenditure

EUR million (to three decimal places)

(*) The average standard allocation, including the costs of 'habillage' as well as taking into account higher living costs in Finland.

(**) To be partially redeployed from the budget lines 07 02 03 (which is part of the LIFE sub-programme for Environment).

EUR million (to three decimal places)

EUR million (to three decimal places)

3.2.2.Estimated impact on ECHA's appropriations

◻    The proposal/initiative does not require the use of operational appropriations

X    The proposal/initiative requires the use of operational appropriations, as explained below:

Commitment appropriations in EUR million (to three decimal places)

Current costs for the scientific and technical work that are covered by the operational budget 2015-2016 amount to about 210.000€ per year and cover service contracts. The transfer to the Agency is expected to create high costs in 2019 for development of new software, which would also be necessary for either alternative approach due to the need to harmonise and improve the reporting of the Member States by creating a database. After this initial phase, operating costs are expected to be stable. An investment is necessary in 2019 in particular for IT investments by the Agency. Once the Agency activities have started in 2019, the overall expenditure of the Agency will be stable while an increase in the workload, in particular the preparation of reports, is expected and will result in a decrease of the "unit cost' per output.

3.2.3.Estimated impact on ECHA's human resources

3.2.3.1.Summary

◻    The proposal/initiative does not require the use of appropriations of an administrative nature

X    The proposal/initiative requires the use of appropriations of an administrative nature, as explained below:

EUR million (to three decimal places)

Officials (AD Grades)
Officials (AST grades)
Contract staff	1	1
Temporary staff
Seconded National Experts

TOTAL

1

1

Estimated impact on the staff (additional FTE) – establishment plan

Estimated impact on the staff (additional) – external personnel

Seconded National Experts	Year N	Year N+1	Year N+2	Enter as many years as necessary to show the duration of the impact (see point 1.6)
Total

Please indicate the planned recruitment date and adapt the amount accordingly (if recruitment occurs in July, only 50 % of the average cost is taken into account) and provide further explanations in an annex.

3.2.3.2.Estimated requirements of human resources for the parent DG

◻    The proposal/initiative does not require the use of human resources.

◻    The proposal/initiative requires the use of human resources, as explained below:

Estimate to be expressed in full amounts (or at most to one decimal place)

XX is the policy area or budget title concerned.

The human resources required will be met by staff from the DG who are already assigned to management of the action and/or have been redeployed within the DG, together if necessary with any additional allocation which may be granted to the managing DG under the annual allocation procedure and in the light of budgetary constraints.

Description of tasks to be carried out:

Description of the calculation of cost for FTE units should be included in the Annex V, section 3.

3.2.4.Compatibility with the current multiannual financial framework

X    The proposal/initiative is compatible with the current multiannual financial framework.

◻    The proposal/initiative will entail reprogramming of the relevant heading in the multiannual financial framework.

◻    The proposal/initiative requires application of the flexibility instrument or revision of the multiannual financial framework 56 .

3.2.5.Third-party contributions

X - The proposal/initiative does not provide for co-financing by third parties.

The proposal/initiative provides for the co-financing estimated below:

EUR million (to three decimal places)

3.3.Estimated impact on revenue

X    The proposal/initiative has no financial impact on revenue.

◻    The proposal/initiative has the following financial impact:

◻    on own resources

◻    on miscellaneous revenue

EUR million (to three decimal places)

For miscellaneous ‘assigned’ revenue, specify the budget expenditure line(s) affected.

Specify the method for calculating the impact on revenue.

(1)    Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC (OJ L 158, 30.4.2004, p. 7.)

(2)    Council Decision 2006/507/EC of 14 October 2004 concerning the conclusion, on behalf of the European Community, of the Stockholm Convention on Persistent Organic Pollutants (OJ L 209, 31.7.2006, p. 1).

(3)    Council Decision 2004/259/EC of 19 February 2004 concerning the conclusion, on behalf of the European Community, of the Protocol to the 1979 Convention on Long-Range Transboundary Air Pollution on Persistent Organic Pollutants (OJ L 81, 19.3.2004, p. 35).

(4)    Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ 196, 16.8.1967, p. 1–98)

(5)    Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1)

(6)    Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1)

(7)    COM (2017) 312 available at: http://ec.europa.eu/environment/legal/reporting/pdf/action_plan_env_issues.pdf

(8)    Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EEC (OJ L 41, 14.2.2003, p. 26–32)

(9)    Directive 2007/2/EC of the European Parliament and of the Council of 14 March 2007 establishing an Infrastructure for Spatial Information in the European Community (INSPIRE) (OJ L 108, 25.4.2007, p. 1)

(10)    COM (2017) 312 and SWD (2017) 230

(11)    Commission Regulation (EU) 2016/460 of 30 March 2016 amending Annexes IV and V to Regulation (EC) No 850/2004 of the European Parliament and of the Council on persistent organic pollutants (OJ L 80, 31.3.2016, p. 17)

(12)    Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals (OJ L 201, 27.7.2012, p. 60)

(13)    COM(2017) 312 final- Actions to Streamline Environmental Reporting: http://ec.europa.eu/environment/legal/reporting/pdf/action_plan_env_issues.pdf  

(14)    Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC (OJ L 158, 30.4.2004, p. 7).

(15)    OJ L 81, 19.3.2004, p. 37.

(16)    OJ L 209, 31.7.2006, p. 3

(17)    OJ L 63, 6.3.2003, p. 29 Convention on the prior informed consent procedure for certain hazardous chemicals and pesticides in international trade.

(18)    OJ L 39, 16.2.1993, p. 3 Convention on the control of transboundary movements of hazardous wastes and their disposal.

(19)    Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).

(20)    Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).

(21)    Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1).

(22)    OJ L 33, 8.2.1979, p. 36. Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).

(23)    OJ L 262, 27.9.1976, p. 201. Directive as last amended by Commission Directive 2004/21/EC (OJ L 57, 25.2.2004, p. 4).

(24)    Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3).

(25)    OJ L 63, 6.3.2003, p. 1. Regulation as last amended by Commission Regulation (EC) No 775/2004 (OJ L 123, 27.4.2004, p. 27).

(26)    Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals (OJ L 201, 27.7.2012, p. 60).

(27)    OJ C 322, 17.11.2001, p. 2.

(28)    OJ L 377, 31.12.1991, p. 20. Directive as amended by Directive 94/31/EC (OJ L 168, 2.7.1994, p. 28).

(29)    OJEU L 354, 28.12.2013, p. 171

(30)    https://ipchem.jrc.ec.europa.eu/RDSIdiscovery/ipchem/index.html and Commission Staff Working Document SWD(2016) 188 final.

(31)    COM (2017) 312 available at: http://ec.europa.eu/environment/legal/reporting/pdf/action_plan_env_issues.pdf

(32)    Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EEC (OJ L 41, 14.2.2003, p. 26).

(33)    Directive 2007/2/EC of the European Parliament and of the Council of 14 March 2007 establishing an Infrastructure for Spatial Information in the European Community (INSPIRE) (OJ L 108, 25.4.2007, p. 1).

(34)    OJ L 184, 17.7.1999, p. 23.

(35)    Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

(36)    Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ P 196, 16.8.1967, p. 1). Directive as last amended by Council Regulation (EC) No 807/2003.

(37)    Council Directive 75/442/EEC of 15 July 1975 on waste (OJ L 194, 25.7.1975, p. 39). Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

(38)    Commission Directive 2001/59/EC of 6 August 2001 adapting to technical progress for the 28th time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ L 225, 21.8.2001, p. 1).

(39)    Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control (OJ L 257, 10.10.1996, p. 26. Directive as last amended by Regulation (EC) No 1882/2003.

(40)    Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (OJ L 334, 17.12.2010, p. 17). 

(41)    Council Directive 96/59/EC of 16 September 1996 on the disposal of polychlorinated biphenyls and polychlorinated terphenyls (PCB/PCT) (OJ L 243, 24.9.1996, p. 31).

(42)    Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EEC (OJ L 41, 14.2.2003, p. 26).

(43)    Commission Decision 2000/479/EC of 17 July 2000 on the implementation of a European pollutant emission register (EPER) according to Article 15 of Council Directive 96/61/EC concerning integrated pollution prevention and control (IPPC) (OJ L 192, 28.7.2000, p. 36).

(44)    ABM: activity-based management; ABB: activity-based budgeting.

(45)    As referred to in Article 54(2)(a) or (b) of the Financial Regulation.

(46)    Details of management modes and references to the Financial Regulation may be found on the BudgWeb site: https://myintracomm.ec.europa.eu/budgweb/EN/man/budgmanag/Pages/budgmanag.aspx .

(47)    Diff. = Differentiated appropriations / Non-diff. = Non-differentiated appropriations.

(48)    EFTA: European Free Trade Association.

(49)    Candidate countries and, where applicable, potential candidates from the Western Balkans.

(50)    Year N is the year in which implementation of the proposal/initiative starts.

(51)    Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc.).

(52)    As described in point 1.4.2. ‘Specific objective(s)…’

(53)    AC = Contract Staff; AL = Local Staff; END = Seconded National Expert; INT = agency staff; JED = Junior Experts in Delegations.

(54)    Sub-ceiling for external staff covered by operational appropriations (former ‘BA’ lines).

(55)    Mainly for the Structural Funds, the European Agricultural Fund for Rural Development (EAFRD) and the European Fisheries Fund (EFF).

(56)    See Articles 11 and 17 of Council Regulation (EU, Euratom) No 1311/2013 laying down the multiannual financial framework for the years 2014-2020.

(57)    As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net amounts, i.e. gross amounts after deduction of 25 % for collection costs.

EUROPEAN COMMISSION

Brussels,22.3.2018

COM(2018) 144 final

ANNEXES

to the

Proposal for a Regulation of the European Parliament and of the Council

on persistent organic pollutants (recast)

ê 757/2010 Art. 1 and Annex .1 (adapted)

è1 293/2016 Art. 1 and Annex

è2 519/2012 Art. 1 and Annex .1(a)

è3 519/2012 Art. 1 and Annex .1(b)

è4 519/2012 Art. 1 and Annex .2

è5 2030/2015 Art. 1 and Annex

ð new

ANNEX I

Part A — Substances listed in the Convention and in the Protocol as well as substances listed only in the Convention

Part B — Substances listed only in the Protocol

ê Corrigendum, OJ L 229, 29.6.2004, p. 5

ANNEX II

LIST OF SUBSTANCES SUBJECT TO RESTRICTIONS

PART A – Substances listed in the Convention and in the Protocol

PART B – Substances listed only in the Protocol

Substance	CAS No	EC No	Conditions of restriction

ANNEX III

LIST OF SUBSTANCES SUBJECT TO RELEASE REDUCTION PROVISIONS

Substance (CAS No)

Polychlorinated dibenzo-p-dioxins and dibenzofurans (PCDD/PCDF)

Hexachlorobenzene (HCB) (CAS No: 118-74-1)

Polychlorinated biphenyls (PCB)

Polycyclic aromatic hydrocarbons (PAHs) 5

ê 757/2010 Art. 1 and Annex .2

Pentachlorobenzene (CAS No 608-93-5)

ê 1342/2014 Art. 1.1 and Annex I (adapted)

è1 460/2016 Art. 1 and Annex

ANNEX IV

List of substances subject to waste management provisions set out in Article 7

ê Corrigendum, OJ L 229, 29.6.2004, p. 5 (adapted)

è1 304/2009 Art. 1 and Annex .2(a)

ANNEX V

WASTE MANAGEMENT

Part 1 Disposal and recovery under Article 7(2)

The following disposal and recovery operations, as provided for in Annex Annexes I IIA and IIB of Directive 75/442/EEC2008/98/EC, are permitted for the purposes of Article 7(2), when applied in such a way as to ensure that the persistent organic pollutant content is destroyed or irreversibly transformed

Pre-treatment operation prior to destruction or irreversible transformation pursuant to this Part of this Annex may be performed, provided that a substance listed in Annex IV that is isolated from the waste during the pre-treatment is subsequently disposed of in accordance with this Part of this Annex.è1  Where only part of a product or waste, such as waste equipment, contains or is contaminated with persistent organic pollutants, it shall be separated and then disposed of in accordance with the requirements of this Regulation. ç In addition, repackaging and temporary storage operations may be performed prior to such pre-treatment or prior to destruction or irreversible transformation pursuant to this part of this Annex.

ê 172/2007 Art. 1 and Annex

Part 2 Wastes and operations to which Article 7(4)(b) applies

The following operations are permitted for the purposes of Article 7(4)(b) in respect of the wastes specified, defined by the six-digit code as classified in Commission Decision 2000/532/EC 11

ê 323/2007 Art. 1 and Annex

Pre-treatment operations prior to permanent storage pursuant to this part of this Annex may be performed, provided that a substance listed in Annex IV that is isolated from the waste during the pre-treatment is subsequently disposed of in accordance with Part 1 of this Annex. In addition, repackaging and temporary storage operations may be performed prior to such pre-treatment or prior to permanent storage pursuant to this part of this Annex.

ê 460/2016 Art. 1 and Annex